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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06910657




Registration number
NCT06910657
Ethics application status
Date submitted
21/03/2025
Date registered
4/04/2025

Titles & IDs
Public title
IDOV-Immune for Advanced Solid Tumors
Scientific title
A First-in-human, Phase I, Multi-center, Open-label, Dose-escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Evidence of Antitumor Activity of IDOV-Immune in Adult Participants With Advanced Solid Tumors
Secondary ID [1] 0 0
VM-002-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colorectal Cancer 0 0
Pancreatic Cancer 0 0
Melanoma 0 0
Ovarian Cancer 0 0
Gastric Cancer 0 0
Esophageal Cancer 0 0
Hepatocellular Carcinoma 0 0
Renal Cell Carcinoma 0 0
Breast Cancer 0 0
Sarcoma 0 0
Bladder Cancer 0 0
Lung Cancer 0 0
Prostate Cancer 0 0
Cervical Cancers 0 0
Head and Neck Cancers 0 0
Adrenal Gland Tumors 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Metabolic and Endocrine 0 0 0 0
Other endocrine disorders
Cancer 0 0 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - IDOV-Immune (oncolytic vaccinia virus)

Experimental: IDOV-Immune Dose Escalation Arm - Participants in this arm will receive a single intravenous (IV) infusion of IDOV-Immune, an investigational oncolytic vaccinia virus, on Day 1 of a 28-day treatment cycle. The study will follow a dose-escalation design, with each successive cohort receiving an increased dose based on safety data and observed dose-limiting toxicities (DLTs). Following dose escalation, expansion cohorts may be enrolled at selected dose levels to further assess safety and preliminary antitumor activity.


Treatment: Other: IDOV-Immune (oncolytic vaccinia virus)
IDOV-Immune is a genetically engineered oncolytic vaccinia virus designed to selectively infect and destroy tumor cells while stimulating the immune system. This study investigates IDOV-Immune as a single intravenous infusion in a first-in-human, Phase 1, dose-escalation trial in participants with advanced solid tumors. The dose will escalate based on safety data, with a goal of identifying the recommended Phase 2 dose (RP2D).
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of Dose-Limiting Toxicities (DLTs)
Timepoint [1] 0 0
First 28 days after treatment (Cycle 1)
Primary outcome [2] 0 0
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Timepoint [2] 0 0
Up to 90 days post-treatment
Primary outcome [3] 0 0
Determination of Maximum Tolerated Dose (MTD)
Timepoint [3] 0 0
Through completion of dose-escalation phase (~24 months)
Primary outcome [4] 0 0
Determination of Recommended Phase 2 Dose (RP2D)
Timepoint [4] 0 0
Through completion of dose-escalation and evaluation of all safety, PK/PD, and clinical activity data (~24 months)
Secondary outcome [1] 0 0
Peak Whole Blood Viral Genome Copy Number
Timepoint [1] 0 0
Up to 28 days post-infusion
Secondary outcome [2] 0 0
Peak Serum Cytokine (IL-12 and CXCL9) Concentration
Timepoint [2] 0 0
Up to 28 days post-infusion
Secondary outcome [3] 0 0
Serum Cytokine (IFN-ß, IFN-?, IL-1ß, IL-6, IL-10, TNF-a, and TGF-ß1) Concentration
Timepoint [3] 0 0
Up to 28 days post-infusion
Secondary outcome [4] 0 0
Objective Response Rate (ORR)
Timepoint [4] 0 0
Up to 12 months
Secondary outcome [5] 0 0
Duration of Response (DOR)
Timepoint [5] 0 0
Up to 12 months
Secondary outcome [6] 0 0
Disease Control Rate (DCR)
Timepoint [6] 0 0
Up to 12 months
Secondary outcome [7] 0 0
Progression-Free Survival (PFS)
Timepoint [7] 0 0
Up to 12 months
Secondary outcome [8] 0 0
Overall Survival (OS)
Timepoint [8] 0 0
Up to 12 months
Secondary outcome [9] 0 0
Incidence of Neutralizing Antibody Response
Timepoint [9] 0 0
Up to 90 days post-treatment

Eligibility
Key inclusion criteria
Key

* Age = 18 years.
* Histologically or cytologically confirmed advanced solid tumors that have progressed despite standard therapy, or for which no standard therapy exists.
* ECOG performance status = 1.
* Measurable disease per RECIST v1.1.
* Adequate organ and bone marrow function.
* At least 28 days since major surgery, prior immunotherapy, or radiotherapy (with exceptions for minor procedures).
* Negative pregnancy test for women of childbearing potential.
* Agreement to use effective contraception during treatment and for 3 months after.
* Ability to provide informed consent and comply with study requirements.

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Prior treatment with an oncolytic virus.
* Active or recent vaccinia virus infection or smallpox/monkeypox vaccination within 10 years.
* Active uncontrolled infection requiring systemic treatment.
* History of hepatitis B, hepatitis C, or HIV (unless meeting protocol-specific criteria).
* Unresolved = Grade 2 toxicities from prior therapies (except hair loss or stable chronic conditions).
* Active or symptomatic autoimmune disease requiring systemic therapy.
* Active or untreated CNS metastases (unless stable per protocol).
* Significant cardiac disease (e.g., NYHA Class III/IV heart failure).
* Interstitial lung disease or prior pneumonitis requiring steroids.
* Conditions requiring chronic immunosuppressive therapy.
* Severe skin disorders or history of pancreatitis.
* Bleeding disorders or history of recent serious thromboembolic events.
* Any medical or psychiatric condition that could interfere with study participation.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/06/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/05/2027
Actual
Sample size
Target
78
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Westmead Hospital - Westmead
Recruitment hospital [2] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Missouri
Country [2] 0 0
United States of America
State/province [2] 0 0
Texas

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
ViroMissile, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Clinical Develoopment
Address 0 0
Country 0 0
Phone 0 0
858-886-7718
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06910657